Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard oscillometric blood pressure measurement and data transmission, with no mention of AI or ML algorithms for analysis or interpretation.

Therapeutic

No.
The device is intended for measuring blood pressure and pulse rate, not to treat or cure a condition.

Diagnostic

Yes
The device is intended for measuring blood pressure and pulse rate, which are diagnostic indicators of health.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "wrist non-invasive blood pressure device" and describes a physical blood pressure meter with a cuff and a radio module for data transmission. This indicates a hardware component is central to the device's function.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The tenso-comfort BPM 105 / BPM 205 is a non-invasive blood pressure monitor. It measures blood pressure and pulse rate directly from the body (at the wrist) without requiring any samples to be taken and analyzed outside the body.

Therefore, based on the provided information, this device falls under the category of a non-invasive medical device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The tenso-comfort BPM 105 /BPM 205 is a wrist non-invasive blood pressure device which is intended for use in measuring blood pressure and pulse rate in adult patient population. The measuring method is an oscillometric blood pressure measurement with automatic sequence and refers to the auscultatory method as the reference standard. The model version BPM 105 is equipped with a radio module to transmit the measurement data to a PC.

The device is not intended for neonatal use.

Product codes

DXN

Device Description

The non-invasive wrist blood pressure meter BPM105 and BPM205 determine the arterial blood pressure by means of the oscillometric blood pressure measuring method. With this method the pressure fluctuations are measured, which develop when depressing pulse-cyclic blood pulses in the compressed arteria under the blood pressure cuff put on. The blood pressure apparatus in the model variant BPM105 is equipped with a radio module, with which the transmission of the stored measured values on a PC is optionally possible (radio interface for PC and software is offered as accessory).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

wrist

Indicated Patient Age Range

adult patient population.
The device is not intended for neonatal use.

Intended User / Care Setting

Lay users

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K051703

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).

Summary

0

510(k) Summary

The assigned 510(k) number is:

Date Prepared:

Submitter Information:

Official Correspondent:

Mrs. Marion Otto Quality Manager Biocomfort GmbH & Co. KG Phone: +49 7158 98016-48 +49 7158 98016-40 Fax: E-mail: otto@biocomfort.de

Burlington, MA 01803 USA Phone: +1 866 294 8267 E-mail: schill@biocomfort.com

Mr. Dieter Schill

President Biocomfort Inc. 23 Third Avenue

Biocomfort Diagnostics GmbH & Co. KG

Registration Number: 3006493236 Owner Operator Number: 10023755

Ko 81498

Bernhaeuser Strasse 17 73765 Neuhausen a.d.F.

May 19, 2008

Germany

US Agent (Contact):

Device Trade Name: Common Name: Device Classification Name: Product Code: Device Classification No.: Regulatory Status:

Predicate Devices: Device Trade Name: 510(k) Number: Device Classification Name: Product Code: Device Classification No .: Regulatory Status:

Device Description:

tenso-comfort BPM 105 / 205 Blood pressure meter System, Test, Non- invasive Blood Pressure meter, Over The Counter DXN Part 870.1130 Class II

Clever TD-3018A Clever TD-3018A K051703 Blood pressure meter, Over The Counter DXN Part 870.1130 Class II

The non-invasive wrist blood pressure meter BPM105 and BPM205 determine the arterial blood pressure by means of the oscillometric blood pressure measuring method. With this method the pressure fluctuations are measured, which develop when depressing pulse-cyclic blood pulses in the compressed arteria under the blood pressure cuff put on. The blood pressure apparatus in the model variant BPM105 is equipped with a radio module, with which the transmission of the stored

06 - 510(k) Summary - Page 1 of 3

DEC 1 7 2008

1

measured values on a PC is optionally possible (radio interface for PC and software is offered as accessory).

Intended Use:

The tenso-comfort BPM 105 /BPM 205 is a wrist non-invasive blood pressure device which is intended for use in measuring blood pressure and pulse rate in adult patient population. The measuring method is an oscillometric blood pressure measurement with automatic sequence and refers to the auscultatory method as the reference standard. The model version BPM 105 is equipped with a radio module to transmit the measurement data to a PC.

The device is not intended for neonatal use..

	SE Discussion:
		Substantial Equivalent
Device	Predicate Devices
		Biocomfort tenso-
comfort BPM 105/ BPM
205	TaiDoc Clever TD-3018A	Discussion of differences
[01]	Indication for
use	The tenso-comfort BPM
105 /BPM 205 is a wrist
non-invasive blood
pressure device which is
intended for use in
measuring blood pressure
and pulse rate in adult
patient population. The
measuring method is an
oscillometric blood
pressure measurement
with automatic sequence
and refers to the
auscultatory method as
the reference standard.
The model version BPM
105 is equipped with a
radio module to transmit
the measurement data to
a PC.	The Clever TD-3018A
Blood Pressure Monitor
provide intended to use
non-invasive measure the
systolic and diastolic
blood pressure and pulse
rate of an adult
individual, over age 18,
at home by using a non-
invasive technique in
which an inflatable cuff is
wrapped around the
wrist. The cuff
circumference is limited
to 5.25"~ 7.75".	The BPM 105 is equipped
with a transmitter to send
the measuring results to a
PC.
[02]	Target
population	Adults,
Lay users	Adults
Lay users	Equivalent
[03]	Measuring
principle	Oscillometric method	Oscillometric method	Equivalent
[04]	Type of results	Pressure: mmHg
Puls: beats/minute	Pressure: mmHg
Puls: beats/minute	Equivalent
[05]	Presentation of
results	LCD Digital Display	LCD Digital Display	Equivalent
[06]	Measurement
range	Pressure: 0 - 300 mmHg
Pulse: 40 - 199
beats/minute	Pressure: 0 - 300 mmHg
Pulse: 40 - 199
beats/minute	Equivalent
[07]	Measuring
accuracy	Pressure: ±3 mmHg
Pulse: ±5% of the value	Pressure: ±3 mmHg or
2% of reading
Pulse: ±4% of the reading	In the same area and
considered equivalent
		Substantial Equivalent
Device	Predicate Devices
		Biocomfort tenso-
comfort BPM 105/ BPM
205	TaiDoc Clever TD-3018A	Discussion of differences
[08]	Inflation	Automatic inflation	Automatic inflation	Equivalent
[09]	Deflation	Electric Valve	Electric Valve	Equivalent
[10]	Pressure
release	Automatic exhaust valve	Automatic exhaust valve	Equivalent
[11]	Pressure
detection	Piezo-resistive silicon
pressure transducer	Piezo-resistive silicon
pressure transducer	Equivalent
[12]	Measuring
period	App. 30 seconds	App. 20 seconds	Equivalent
[13]	Operation
environment	10°C - 40°C
50°F - 104°F	10°C - 40°C
50°F - 104°F	Equivalent
[14]	Storage
environment	-20°C - 60°C
-4°F - 140°F
10% - 95% relative
humidity	-20°C - 60°C
-4°F - 140°F
10% - 95% relative
humidity	Equivalent
[15]	Battery life	App. 300 measurements	App. 200 uses	Improved energy
management and
considered equivalent
[16]	Cuff size	135mm - 220mm
5 ½ in - 8 ⅜ in	135mm - 195mm
5 ¼ in - 7 ¾ in	Slightly larger cuff and
considered equivalent
[17]	Dimensions	70 x 90 x 26 mm	76 x 64 x 29 mm	Slightly different
dimension due to
corporate design. The
devices are considered
equivalent.
[18]	Weight	Ca. 140 g (without
batteries)	132 g (with batteries)	Equivalent
[19]	Mobility	Hand-held	Hand-held	Equivalent
[20]	Memory
Capability	110 measurements per
user (up to 8 users) with
date and time	352 sets of reading with
date and time	Different number of
measurement due to the
user management.
It is considered
equivalent.
[21]	Power supply	Two 1.5 alkaline batteries
type AAA/LR03	Two 1.5 alkaline batteries
type AAA/LR03	Equivalent
[22]	Connectivity	Wireless interface with
2.4 GHz according to
IEEE802.15.4, with 10 m
indoor range	None	The model BPM 105
provides the option to
communicate via wireless
technology to a PC which
is set up for the interface
protocol

06 – 510(k) Summary – Page 2 of 3

2

Discussion of the Substantial Equivalence Decision:

The only difference between the BPM 105/205 and the predicate device is the ability to communicate rit only unceless connection. This feature does neither affect nor even represent the measurement of with a r e vireless connection is for the upload of measurement data and the set up of basic device functions.

3

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's emblem in the center. The emblem is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 7 2008

Mr. Dieter Schill President Biocomfort Inc. 23 Third Avenue Burlington, MA 01803

Re: K081498

Trade/Device Name: tenso-comfort BPM 105/205 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: December 12, 2008 Received: December 17, 2008

Dear Mr. Schill:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part

4

Page 2 - Mr. Dieter Schill

807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

07 Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

5

Indications for Use

510(k) Number (if known): K081498

Device Name: tenso-comfort BPM 105 / 205

The tenso-comfort BPM 105 /BPM 205 is a wrist non-invasive blood pressure device which is intended for use in measuring blood pressure and pulse rate in adult patient population. The measuring method is an oscillometric blood pressure measurement with automatic sequence and refers to the auscultatory method as the reference standard. The model version BPM 105 is equipped with a radio module to transmit the measurement data to a PC.

The device is not intended for neonatal use.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(Please Do not Write Below This Line-Continue on another Page OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
	12/17/08
Division of Cardiovascular Devices
	4081498

510(k) Number